truSculpt

GUDID 00816722021403

truSculpt RF Device

CUTERA, INC.

Radio-frequency skin contouring system

• Primary Device ID: 00816722021403
• NIH Device Record Key: 16be0c7a-0146-452a-9f78-e0521d9e9afe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: truSculpt
• Version Model Number: truSculpt
• Company DUNS: 041071643
• Company Name: CUTERA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-415-657-5500
• Email: info@cutera.com
• Phone: 1-415-657-5500
• Email: info@cutera.com
• Phone: 1-415-657-5500
• Email: info@cutera.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816722021403 [Primary]

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [truSculpt]

• 00816722021410: truSculpt 2 MHz RF Device
• 00816722021403: truSculpt RF Device